Coronary artery disease (CAD) is the single largest killer of Americans, producing acute myocardial infarctions (AMIs) and subsequent heart failure (HF). The dearth of mechanistic studies and the recognition of unmet treatment needs of patients with cardiovascular disease in the United States led NHLBI to establish the Cardiovascular Cell Therapy Research Network (CCTRN). The Network was to build upon contemporary (2006) findings of the cell therapy basic science community, translating newly acquired information from preclinical and pilot data to the clinical setting in the Phase l/ll study paradigm. The current CCTRN-1 consists of the Cleveland Clinic Foundation (CCF), the University of Florida (UFL), the Minneapolis Heart Institute Foundation (MHIF), the Texas Heart Institute (THI), and Vanderbilt University (VU);as well as five cell processing laboratories, one at each main center;seven satellite clinical centers (University Hospitals, DeBakey Veterans Administration, Pepin Heart Hospital, St. Paul Heart Clinic, Metropolitan Cardiology Consultants, the University of Minnesota, and the Mayo Clinic);a cell processing quality control laboratory (CP-QCL);five core laboratories;the NHLBI Project Office;and the DCC which provides Network trial management and data analyses. The University of Texas School of Public Health (UTSPH) Coordinating Center for Clinical Trials (CCCT) has served as the Data Coordinating Center (DCC) for the CCTRN since the Network's inception in January 2007. The personnel have been, and continue to be, committed to CCTRN's success. The DCC works closely with NHLBI and the Steering Committee chair in decision making and the discharge of critical leadership responsibilities. In CCTRN-2, the DCC will continue to assist the Network in research endeavors by providing support in the following areas, protocol development, regulatory affairs, statistical leadership, financial management, meeting logistics, data/web capability, quality control, as well as outreach and dissemination. The DCC will also strive to identify opportunities for expanded growth and collaboration with other Networks, industry partners, and other respected Investigators in the field of cell therapy.

Public Health Relevance

The CCTRN is to promote evaluation of novel cell-based treatment strategies for individuals with cardiovascular disease. The Network provides support to maintain an infrastructure to develop, coordinate, and conduct multiple collaborative clinical trials designed to improve cardiovasular disease outcomes.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZHL1-CSR-O (F1))
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Skarlatos, Sonia
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University of Texas Health Science Center Houston
Biostatistics & Other Math Sci
Schools of Public Health
United States
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Moyé, Lem (2016) Statistical Methods for Cardiovascular Researchers. Circ Res 118:439-53
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